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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K241319
Device Name SKR 3000
Applicant
Konica Minolta, Inc.
1 Sakura-machi
Hino-shi
Tokyo,  JP 1918511
Applicant Contact Makoto Sumi
Correspondent
Konica Minolta Healthcare Americas, Inc.
411 Newark Pompton Turnpike
Wayne,  NJ  07470
Correspondent Contact Jan Maniscalco
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received05/10/2024
Decision Date 11/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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